Commission Implementing Regulation (EU) 2020/107 of 23 January 2020 concerning the authorisation of ponceau 4R as a feed additive for dogs, cats and ornamental fish (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/107
• Articles: 4

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 13 August 2020 in accordance with the rules applicable before 13 February 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substance specified in the Annex which are produced and labelled before 13 February 2022 in accordance with the rules applicable before 13 February 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance of kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Colourants. (i) substances that add or restore colour in feedingstuffs

2a124

Ponceau 4R

Additive composition

Ponceau 4R described as the sodium salt as the principal component.

Solid form (powder or granules)

Cats

—

—

31

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye, skin, oral and breathing protection.

13 February 2030

Characterisation of the active substance as the sodium salt

Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.

The calcium and the potassium salts are also permitted

Chemical formula: C 20 H 11 N 2 O 10 S 3 Na 3

Solid form (powder or granules) produced by chemical synthesis

CAS No: 2611-82-7

Purity criteria

—

Total colouring matters calculated as the sodium salt ≥ 80 % (assay);

—

Subsidiary colouring matter ≤ 1 %;

—

Organic compounds other than colouring matters ≤ 0,5 %;

—

Unsulfonated primary aromatic amines (calculated as aniline) ≤ 0,01 %.

Analytical method

( 1 )

For the quantification of total colouring matters content of ponceau 4R in the feed additive:

Spectrophotometry at 505 nm and titration with Titanous chloride as described in Commission Regulation (EU) No 231/2012 referring to FAO JECFA Combined Compendium for Food Additive Specifications (Analytical methods Vol. 4); and the Monograph No 11 (2011) ‘Ponceau 4R’.

For the quantification of ponceau 4R in feedingstuffs:

High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)

Dogs

—

—

37

Category: Sensory additives. Functional group: Colourants. (iii) substances which favourably affect the colour of ornamental fish or birds

2a124

Ponceau 4R

Additive composition

Ponceau 4R described as the sodium salt as the principal component.

Solid form (powder or granules)

Ornamental fish

—

—

137

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye, skin, oral and breathing protection.

13 February 2030

Characterisation of the active substance as the sodium salt

Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components

The calcium and the potassium salts are also permitted

Chemical formula: C 20 H 11 N 2 O 10 S 3 Na 3

Solid form (powder or granules) produced by chemical synthesis

CAS No: 2611-82-7

Purity criteria

—

Total colouring matters calculated as the sodium salt ≥ 80 % (assay);

—

Subsidiary colouring matter ≤ 1 %;

—

Organic compounds other than colouring matters ≤ 0,5 %;

—

Unsulfonated primary aromatic amines (calculated as aniline) ≤ 0,01 %.

Analytical method

( 1 )

For the quantification of total colouring matters content of ponceau 4R in the feed additive:

Spectrophotometry at 505 nm and titration with Titanous chloride as described in Commission Regulation (EU) No 231/2012 referring to FAO JECFA Combined Compendium for Food Additive Specifications (Analytical methods Vol. 4); and the Monograph No 11 (2011) ‘Ponceau 4R’.

For the quantification of ponceau 4R in feedingstuffs:

High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports